510(k) Report

FDA applicant

Cardio Vascular Concepts, Inc.

Portola Valley, CA2 decisions1995–19950 recalls

FDA records 2 decisions for Cardio Vascular Concepts, Inc. (Portola Valley, CA) in 1995: 2 510(k) clearances. Most are in product codes DWX (Stripper, Artery, Intraluminal) and DYB (Introducer, Catheter). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardio Vascular Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Vascular Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio Vascular Concepts, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWXStripper, Artery, Intraluminal1decision
  • DYBIntroducer, Catheter1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K950813Mollring CutterCardio Vascular Concepts, Inc. · 19951cites it

What has FDA decided for it lately?

  • K950155Rapid-Trak (TM) Introducer SheathCardio Vascular Concepts, Inc. · 1995
  • K950813Mollring CutterCardio Vascular Concepts, Inc. · 1995

All 2 as Cardio Vascular Concepts, Inc. →